SSD AF (Topical)

Silver sulfadiazine cream is used to prevent and treat infections in wounds for patients with second- and third-degree burns. Patients with severe burns or burns covering a large area of the body must be treated in a hospital.

Silver sulfadiazine is an antibiotic. It works by killing bacteria or stopping its growth.

This medicine is available only with your doctor's prescription.

It is important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working properly and to check for any problems or unwanted effects that may be caused by this medicine.

If your skin infection or burn does not improve within a few days or weeks (for more serious burns or burns over larger areas), or if it gets worse, check with your doctor.

Do not use this medicine for a skin problem that has not been checked by your doctor.

Check with your doctor right away if you have the following symptoms while using this medicine: bleeding gums, cough or hoarseness, fever with or without chills, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, unusual bleeding, bruising, or weakness, or yellow skin or eyes. These could be symptoms of a blood disorder.

Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

This medicine may rarely stain skin brownish gray.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies on the effects of silver sulfadiazine topical in children have not been done. Its safety and effectiveness have not been established.

Using silver sulfadiazine topical is not recommended for premature or newborn babies who are 2 months old or younger.

Geriatric

Studies so far have not shown any specific problems in older adults that would make silver sulfadiazine topical less useful.

Breast Feeding

There are no adequate studies that show the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these cases, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are important but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide to not treat you with this medication or change some of your other medicines.

• Methenamine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Methotrexate

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Aminolevulinic Acid

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain foods, as interactions can occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—Use with caution. This condition may cause blood problems.

• Kidney disease or
• Liver disease—Use with caution. The effects might be stronger due to slower removal of the medicine from your body.

• Porphyria—Using this medicine may lead to a severe episode of porphyria.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Incidence not known

• Back, leg, or stomach pains
• Blistering, peeling, or loosening of the skin
• Blue-green to black skin discoloration
• Dark urine
• Fever with or without chills
• General body swelling
• Increased sensitivity of the skin to sunlight, especially in patients with burns on large areas
• Intense itching of burn wounds
• Light-colored stools
• Lower back or side pain
• Nausea or vomiting
• Pinpoint red spots on the skin
• Red skin lesions, often with a purple center
• Red, swollen skin
• Skin rash
• Sores, ulcers, or white spots in the mouth or on the lips
• Swollen or painful glands
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Upper right abdominal or stomach pain
• Yellow eyes and skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Brownish-gray skin discoloration
• Burning feeling on treated areas

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Silvadene
• SSD
• SSD AF
• Thermazene

In Canada

• Flamazine
• Ssd

Available Dosage Forms:

• Cream

Therapeutic Class: Antibacterial

Chemical Class: Sulfonamide

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina.

To use:

• Before applying this medicine, clean the affected areas. Remove dead or burned skin and other debris.
• Wear sterile gloves to apply this medicine. Apply a thin layer (about 1/16 inch) of silver sulfadiazine to the affected areas. Keep the affected areas covered with the medicine at all times.
• If this medicine is rubbed off the affected areas by moving around or if it is washed off during bathing, showering, or the use of a whirlpool bath, reapply the medicine.
• After this medicine has been applied, the treated areas may be covered with a dressing or left uncovered as desired.

To help clear up your skin or burn infection completely, keep using this medicine for the full time of treatment. You should keep using this medicine until the burned area has healed or is ready for skin grafting. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream): For burn wound infections: Adults—Apply to the affected areas one or two times a day. Children older than 2 months of age—Use and dose must be determined by the doctor. Premature infants and infants 2 months of age and younger—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.